Claire Dunn, IRB Program Director for CU Boulder, has gotten back to us with a question we posed earlier in spring semester: Can researchers request information about the vaccine status of research participants during study enrollment?
The short answer is you can ask in some cases with IRB approval, but you cannot use this information to exclude participants.
If your protocol places a vaccinated researcher at extra risk for contracting covid (prolonged contact with a potentially infectious person in an enclosed space), or having covid would contaminate data being collected, you are still not able to use vaccine status to exclude participants. The recommendation in these cases is to require all study participants to show up with a recent negative test result.
Please read Claire's summary of the board deliberations and the official guidance below.
From your Director, Tammy Sumner
IRB Summary and Guidance
Both IRB boards have met to discuss how to advise researchers moving forward and this is a summary of their final thoughts:
The board decided that requiring a participant to be vaccinated in order to participate in research not directly related to vaccine status is not ethical since not everyone is able to take the vaccine for medical or other personal reasons. The IRB will continue to recommend that PIs follow the return to research guidelines as set forth by the institution.
We are advising PI’s that if participating in a study puts an unvaccinated person at increased risk then this risk should be explained to the participant in the consent form so they can decide if they wish to be in the study. Suitable methods of minimizing the risk of spreading COVID-19 should be included in the protocol, for example, cleaning, handwashing, wearing masks and social distancing (same as we have been doing since the start of the pandemic).
Investigators can add a question to screening tools asking about vaccination status, which would require an amendment be approved by the IRB before implementation.
I know it is an extra step but if our guidance is not working for some investigators then we are happy to discuss the research and see if the study might require the participant to be vaccinated.
We are going to add the following language to the IRB website:
"As campus operations move forward, the IRB continues to recommend that PIs follow the return to research guidelines set forth by the institution. If participation puts an unvaccinated person at increased risk, this risk should be disclosed to subjects in the consent form so they can make an informed decision about participation. Also note that it is unethical to require a subject to be vaccinated in order to participate in research that is not directly related to vaccine status as not everyone is able to take the vaccine for medical or other personal reasons. Researchers should continue to follow State and University recommended methods for minimizing the risk of spreading COVID-19."
Claire Dunn, IRB Program Director